Department of Health and Human Services September 2010 – Federal Register Recent Federal Regulation Documents
Results 251 - 300 of 364
Family-to-Family Health Information Center Program
The Health Resources and Services Administration (HRSA) will be transferring the Vermont Family-to-Family Health Information Center (F2F HIC) grant (H84MC00002) from the Parent to Parent (P2P) of Vermont to the Vermont Family Network, Inc. (VFN) in Williston, due to an organizational merger involving these entities and to ensure the continued provision of health resources, financing, related services, and parent-to-parent support for families with children and youth with special health care needs (CYSHCN) in the state of Vermont.
Family-to-Family Health Information Center Program
The Health Resources and Services Administration (HRSA) will be transferring the Florida Family-to-Family Health Information Center (F2F HIC) grant (H84MC00006) from the Florida Institute of Family Involvement (FIFI) to the Family Caf[eacute] in Tallahassee due to financial difficulties resulting in closure of FIFI facilities and programs. This action ensures the continued provision of health resources, financing, related services and parent-to-parent support for families with children and youth with special health care needs (CYSHCN) in the state of Florida.
Schmid Laboratories, Inc. et al.; Withdrawal of Approval of Five New Drug Applications
The Food and Drug Administration (FDA) is withdrawing approval of five new drug applications (NDAs) from multiple holders of these applications. The basis for the withdrawals is that the holders of the applications have repeatedly failed to file required annual reports for the applications.
Request for Nominations for AHRQ Study Section Members
In accordance with Title IX of the Public Health Service Act, see 42 U.S.C. 299c-1, and AHRQ's grant and contract regulations, 42 CFR part 67, applications submitted to AHRQ will be evaluated using the AHRQ peer review process to ensure a fair, equitable, and unbiased evaluation of their scientific and technical merit. The initial peer review of grant applications involves an assessment conducted by panels of experts established to include pertinent scientific disciplines and medical specialty areas. The confidential part of the peer review meetings devoted to critical evaluations will be closed meetings in accordance with section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2). AHRQ is seeking nominations to fill approximately 20 to 30 percent of its study section membership, across the following study sections: (1) Health System Research (HSR), (2) Health Care Technology and Decision Sciences (HCTDS), (3) Health Care Quality and Effectiveness Research (HCQER), and (4) Health Care Research Training (HCRT). The primary research foci and functions of these four study sections are described on the AHRQ Web site: (http:Ilwww.AHRQ .qovlfundlpeerrevlpeerdesc. htm). Individuals from the health services research and health care community who could serve as peer reviewers on these study sections are sought to replace study section members whose terms have expired. In sending your nomination, please specify the nominee's professional/ scientific/technical expertise, affiliations and full contact information, if this information is available. Factors that will be considered in the selection of individuals to serve on study sections include: competence in a scientific, technical or clinical discipline or research specialty, particularly in health services research; fairness and evenhandedness in judgment and review; ability to work effectively in a group context; and commitment to complete work assignments. A diversity of perspectives is valuable to AHRQ's work. To help obtain a diversity of perspectives among nominees, AHRQ encourages nominations of women and members of minority populations. AHRQ also seeks broad geographic representation.
Determination of Regulatory Review Period for Purposes of Patent Extension; ULORIC
The Food and Drug Administration (FDA) has determined the regulatory review period for ULORIC and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; SAPHRIS
The Food and Drug Administration (FDA) has determined the regulatory review period for SAPHRIS and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
Part C Early Intervention Services Grant Under the Ryan White HIV/AIDS Program
HRSA will be awarding non-competitive Part C funds under The Ryan White HIV/AIDS Program to support comprehensive primary care services for persons living with HIV/AIDS, including primary medical care, laboratory testing, oral health care, outpatient mental health and substance abuse treatment, specialty and subspecialty care, referrals for health and support services and adherence monitoring/ education services to the Tutwiler Clinic to ensure continuity of critical HIV medical care and treatment services, to clients in Marks, Mississippi, and the surrounding counties.
Determination of Regulatory Review Period for Purposes of Patent Extension; REPEL-CV
The Food and Drug Administration (FDA) has determined the regulatory review period for REPEL-CV and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that medical device.
Submission for OMB Review; Comment Request; the Framingham Heart Study (FHS)
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval the information collection listed below. This proposed information collection was previously published in the Federal Register on May 10, 2010, pages 25863-4, and allowed 60-days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: The Framingham Heart Study. Type of Information Request: Revision (OMB No. 0925-0216). Need and Use of Information Collection: The Framingham Heart Study will conduct examinations and morbidity and mortality follow-up for the purpose of studying the determinants of cardiovascular disease. Examinations will be conducted on the original, offspring, and Omni Cohorts. Morbidity and mortality follow-up will also occur in all of the cohorts (original, offspring, third generation, and Omni). Frequency of response: The participants will be contacted annually. Affected public: Individuals or households; businesses or other for profit; small businesses or organizations. Types of Respondents: Adult men and women; doctors and staff of hospitals and nursing homes. The annual reporting burden is as follows: Estimated Number of Respondents: 6,921; Estimated Number of Responses per Respondent: 1; Average Burden Hours Per Response: .88; and Estimated Total Annual Burden Hours Requested: 6,091. The annualized cost to respondents is estimated at: $222,040. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.
Development of Set 24 Toxicological Profiles
The Agency for Toxic Substances and Disease Registry (ATSDR) of the Department of Health and Human Services is developing Set 24 Toxicological Profiles. Set 24 Toxicological Profiles consists of one new draft and one updated draft. Electronic access to these documents will be available at the ATSDR Web site: https://www.atsdr.cdc.gov/ toxpro2.html.
Draft Guidance for Industry on Suicidality: Prospective Assessment of Occurrence in Clinical Trials; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Suicidality: Prospective Assessment of Occurrence in Clinical Trials.'' The purpose of this guidance is to assist sponsors in prospectively assessing the occurrence of treatment-emergent suicidality in clinical trials of drug and biological products. Specifically, this guidance addresses FDA's current thinking regarding the importance of suicidality assessment in psychiatric and nonpsychiatric drug trials and the general principles for how best to accomplish this assessment during drug development.
Determination of Regulatory Review Period for Purposes of Patent Extension; IXIARO
The Food and Drug Administration (FDA) has determined the regulatory review period for IXIARO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human biological product.
Meeting of the Chronic Fatigue Syndrome Advisory Committee
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Chronic Fatigue Syndrome Advisory Committee (CFSAC) will hold a meeting. The meeting will be open to the public.
Cardiovascular Devices; Reclassification of Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters
The Food and Drug Administration (FDA) is reclassifying the device type, standard percutaneous transluminal coronary angioplasty (PTCA) catheters, from class III (premarket approval) into class II (special controls). Cutting/scoring PTCA catheters remain in class III and continue to require premarket approval applications (PMAs). FDA is reclassifying these devices in accordance with the Federal Food, Drug, and Cosmetic Act (the act). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled ``Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters'' that will serve as the special control for the reclassified device type.
Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters.'' The guidance was developed as a special control to support the reclassification of PTCA catheters, other than cutting/scoring PTCA catheters, from class III (premarket approval) into class II (special controls). This guidance describes a means by which PTCA catheters, other than cutting/scoring PTCA catheters, may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule that codifies the reclassification of this device type from class III (premarket approval) into class II (special controls).
Oral Dosage Form New Animal Drugs; Tiamulin
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Novartis Animal Health US, Inc. The supplemental NADA provides for use of an increased strength of tiamulin concentrate solution in the drinking water of swine for the treatment of certain bacterial respiratory and enteric diseases.
Ophthalmic and Topical Dosage Form New Animal Drugs; Gentamicin and Betamethasone Ophthalmic Solution
The Food and Drug Administration (FDA) is amending the animal drug regulations to codify the conditions of use of an approved new animal drug application (NADA) for gentamicin sulfate and betamethasone acetate ophthalmic solution. This action is being taken to comply with the Federal Food, Drug, and Cosmetic Act and to improve the accuracy of the regulations.
Determination of Regulatory Review Period for Purposes of Patent Extension; EFFIENT
The Food and Drug Administration (FDA) has determined the regulatory review period for EFFIENT and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
Animal Models-Essential Elements To Address Efficacy Under the Animal Rule; Notice of Public Meeting; and Reopening of Comment Period
The Food and Drug Administration's (FDA or agency) Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) are announcing a public meeting to solicit comments and concerns of industry, other government agencies, and interested parties on the regulatory and scientific challenges as addressed in the draft document entitled ``Guidance for Industry: Animal ModelsEssential Elements to Address Efficacy Under the Animal Rule'' dated January 2009 (Draft Guidance), and as related to the development of medical countermeasures under the ``Animal Rule'' with respect to chemical, biological, radiological, or nuclear (CBRN) threats. Comments on these issues will be considered in connection with the development of a final version of the Draft Guidance.
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